Manufacturing Specialist
Location:
Rockville , Maryland
Posted:
December 14, 2017
Reference:
WD141911
Basic qualifications:
BA / BS in a scientific or technical discipline, and 5+ years of demonstrated technical competency in biopharmaceutical manufacturing processing.
• Previous experience in a biopharmaceutical manufacturing facility (operations experience preferred)
• Previous experience in production control systems (Delta-V , CCDARTS, Unicorn, or similar)
• Previous experience in process deviation investigations and remediation
• Experience with SAP and SAP processes
• Previous experience authoring and/or revising technical documents
• Knowledge of cGMP requirements and practices and previous experience in a cGMP setting

Preferred qualifications:
• Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time
• Strong organizational skills
• Excellent communication and technical writing skills
• Ability to support and/or lead system troubleshooting efforts
• Participate in cross-functional teams to solve production problems
• Must be willing to work shifts
• Ability to collect, assess, and generate and depict conclusions from large quantities of production data

Details:
Reporting into the Specialist team, the role will assist with execution of the production schedule by troubleshooting and remediating operational and process issues, executing root cause investigations, owning/authoring deviations and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.

• Initiates Quality Records and conducts deviation investigations.
• Leads or assists in investigations including root cause analysis and assesses product impact using input from various departments
• Develops, executes and oversees CAPAs
• Supports Tech transfer and process monitoring support as needed
• Revision and management of manufacturing documents such as Batch Records and SOPs
• Leads or supports Continuous Improvement projects
• Conducts data gathering, trending, and data presentation as needed to support investigations
• Assists with shutdown/changeover and campaign scheduling and schedule management
• Support internal and external audits as needed

Contact information:

You may apply for this position online by selecting the Apply now button.
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